Russian clinical trial approvals up 9% in 2008

The Russian agency cleared a total of 615 new trials in 2008, 282 of which were Phase III studies, 152 Phase II, 62 Phase IV and 38 Phase I, according to the latest report from Moscow-based contract research organisation (CRO) Synergy Research Group. The number of Phase III trials rose by 22% over 2007, while there were 4% fewer Phase II studies and 3% more Phase IV studies. The Phase I tally rose by 19% year-on-year.

The majority (59%) of the studies approved by RZN in 2008 were multinational, multicentre clinical trials, although there were 1.2% fewer of these (364 studies) than in 2007. Russian companies were still the leading sponsors, with a total of 201 trials, followed by companies from the US (145), Germany (60), the UK (43) and Switzerland (34).

In terms of individual companies, Novartis was the most active sponsor of new clinical trials in Russia during 2008 (22 studies), with Sanofi-Aventis close behind at 21 trials. GlaxoSmithKline recruited the most patients – more than 8,000 – for new trials in Russia last year. Among domestic pharmaceutical companies, Valenta started the most new trials in Russia (14) last year, followed by ZAO Biocad (11) and OAO Sintez (nine).

Nearly three-quarters or 73% of the clinical trials approved in Russia during 2008 were in one of seven therapeutic areas: oncology (91 trials), the circulatory system (87), the respiratory system (60), endocrine and metabolic diseases (57), the musculoskeletal system (54), infectious diseases (51) and diseases of the central nervous system (50).

The US Food and Drug Administration conducted 13 inspections at Russian investigative sites last year, Synergy Research noted. With seven of these, “no objectionable conditions or practices” were found while six of the inspections resulted in Voluntary Action Indicated, the CRO said.